GE Gets Approval for 3D Mammogram Machine

General Electric Co. recently won FDA approval to offer its 3-D breast imaging technology in the U.S. The mammography system, known as SenoClaire, is quickly adding competition to the market dominated by Hologic.

Also known as tomosynthesis, 3-D imaging combines X-rays taken from multiple angles to produce a more detailed picture than regular mammograms. Although more expensive than regular mammography, studies show the new technology finds more cancers with fewer false alarms. Typically, insurers and Medicare don’t provide extra reimbursement for 3-D mammograms. In fact, some hospitals charge patients an extra $50-75 per exam..

Hologic, which has had the only approved 3-D breast-imaging device in the U.S. since 2001, estimates that more than six million U.S. women will have one of its 3-D mammograms this year, about 17% of all those screened.

GE notes that half of the 4,000 GE breast-imaging devices in use in the U.S. can be upgraded to use its new SenoClaire system, which uses the same amount of radiation as the regular 2D mammogram.

Rachael Bennett, a clinical analyst at MDBuyline, a health-research firm, said many hospitals purchased Hologic equipment because it was the only 3-D breast-imaging system available, while others have been waiting for SenoClaire to win FDA approval.

“We may see a big influx of GE purchases,” she said. The competition will give hospitals that want to purchase 3-D systems added negotiating power, she added.